Several patch devices have been used for applying medication to the skin. For example, U.S. Pat. Nos. 4,675,009; 5,536,263; and 5,741,510 each describe a drug dispensing device for the delivery of medication to the skin. While the patches disclosed are generally effective in the delivery of a medicament (e.g., antipruritic) to the skin, there exists a need for additional protective, adhesive patches that can adhere to FDA regulations.
FDA regulations (e.g., Federal Register, Vol. 48, No. 27, xc2xa7341) regulate what components (i.e., xe2x80x9cactive ingredientsxe2x80x9d), in a specified amount, may be described as relieving itching (i.e., contains a topical antipruritic). In order to follow FDA regulations, therefore, only a select number of active ingredients that are able to relieve itching, in a specified amount, may be included in an adhesive patch when the patch is described as a relieving itching. Consequently, it is difficult to manufacture a vapor permeable adhesive patch that includes a topical antipruritic, while at the same time maintaining (a) the solubility and stability of the active ingredients in the therapeutic formulation, (b) the pressure sensitive adhesive properties of the therapeutic formulation, and (c) following FDA regulations.
Accordingly, there is a need for a protective adhesive patch that can be topically applied, that can relieve topical discomfort, that can prevent the user from touching the topical discomfort, and that can cover the entire area of the skin inflicted with the topical disorder. Preferably, the patch is vapor permeable (i.e., breathable).
The patch should be able to maintain the solubility and stability of the medicament (e.g., topical antipruritic) during the manufacturing, packaging, shipping, and/or storage of the patch, while maintaining the pressure sensitive adhesive properties of the therapeutic formulation. In addition, the patch should adhere to FDA regulations (e.g., Federal Register, Vol. 48, No. 27, xc2xa7348).
The present invention provides an adhesive patch. The adhesive patch includes a backing of a flexible sheet of water insoluble porous material. The backing has a front side and a back side and a therapeutic formulation positioned on at least a portion of the front side of the backing. The therapeutic formulation includes a medicament useful for relieving topical discomfort and a pressure sensitive adhesive.
The invention also provides a second adhesive patch. The second adhesive patch includes a backing of a flexible sheet of water insoluble porous material. The backing has a front side and a back side and a therapeutic formulation positioned on at least a portion of the front side of the backing. The therapeutic formulation includes a medicament useful for relieving topical discomfort and a pressure sensitive adhesive. The second adhesive patch can effectively cover the entire surface of skin inflicted with the topical disorder.
The invention also provides a third adhesive patch. The third adhesive patch includes a backing of a flexible sheet of water insoluble porous material. The backing has a front side and a back side and an ointment positioned on at least a portion of the front side of the backing. The ointment includes a medicament useful for relieving topical discomfort and a pressure sensitive adhesive.
The invention also provides a method for alleviating topical discomfort. The method includes applying to the area of the skin inflicted with the topical disorder an adhesive patch of the present invention.
The invention also provides a method for protecting skin inflicted with a topical disorder. The method includes applying an adhesive patch of the present invention to the area of the skin inflicted with the topical disorder.
The invention also provides a method for facilitating the healing process of skin inflicted with a topical disorder. The method includes applying an adhesive patch of the present invention to the area of the skin inflicted with the topical disorder.